MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035467200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during right internal carotid artery (ica) c5 aneurysm procedure, the operator used the guidewire to bring the microcatheter to the aneurysm.Next, the operator framed the aneurysm with the subject coil and inserted the subject coil to go into the aneurysm.However, the operator did not control the tension and the microcatheter went into the parent vessel.The operator tried to retract the subject coil to deliver again but during the retraction into the introducer sheath the subject coil fractured at the detachment point.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Manufacturing date ¿ added.Device evaluated by mfg ¿updated.Expiration date - added.Product available to stryker ¿ updated.Returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the delivery wire was seen to be kinked/bent in multiple areas.The main coil was found to be stretched.The main coil was seen to be kinked/bent.The main coil was seen to be separated from the delivery wire.Functional inspection was not required.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported main coil broken/fractured during use was not confirmed during the analysis.However, the analysis results are consistent with the event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that no anomalies were noted to the device during preparation/prior to use, continuous flush was maintained.During analysis the main coil was seen to be kinked, stretched and prematurely detached and delivery wire was noticed kinked.In the case of this complaint, it is most likely that the coil was manipulated and retracted to deliver again and during retracting back into introducing sheath, the coil detached.A probable cause of procedural factors will be assigned to the reported event 'main coil broken/fractured during use', and to the analyzed events 'main coil stretched', ¿main coil kinked/bent¿, 'main coil prematurely detached/separated during use' since these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.It can be presumed that the delivery wire was kinked during the procedure as excessive force may have been applied when the coil was retracted.Because this defect appears to be associated with handling of the product or portion of the product during the procedure, a probable cause of handling damage will be assigned to the analyzed event 'coil delivery wire kinked/bent'.
Event or Problem Description
It was reported that during right internal carotid artery (ica) c5 aneurysm procedure, the operator used the guidewire to bring the microcatheter to the aneurysm.Next, the operator framed the aneurysm with the subject coil and inserted the subject coil to go into the aneurysm.However, the operator did not control the tension and the microcatheter went into the parent vessel.The operator tried to retract the subject coil to deliver again but during the retraction into the introducer sheath the subject coil fractured at the detachment point.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 STANDARD 7MM X 20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 18698067
• Report Number: 3008881809-2024-00061
• Device Sequence Number: 18225846
• Product Code: HCG
• UDI-Device Identifier: 04546540676306
• UDI-Public: 04546540676306
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/29/2025
• Device Catalogue Number: M0035467200
• Device Lot Number: 23677595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/03/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR SL-10 MICROCATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER); TARGET COIL (STRYKER)
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Race: Asian